WHO发布新的确认验证指南-2018.9-附中英文翻译APPENDIX 6 GUIDELINES ONQUALIFICATION 附录6-确认指南
1. Principle 原则
2. Scope 范围
3. Glossary 术语
4. General 概述
5. Ur requirementspecifications 用户需求说明
6. Designqualification 设计确认
7. Factoryacceptance test and site acceptance test FAT和SAT
8. Installationqualification 安装确认
9. Operationalqualification 运行确认
10. Performancequalification 性能确认
11. Periodicreview and requalification 定期审核和再确认
1. PRINCIPLE原则
1.1 In principle,premis, systems, utilities and equipment should be appropriately designed, installed, qualified, operated, cleaned andmaintained to suit their intended purpo.
北京市区旅游景点原则上，厂房、系统、公用设施和设备应进行适当的设计、安装、确认、运行、清洁和维护，
以符合其预期目的。
1.2 Qualitymanagement systems should be in place to ensure that the remain in
aqualifiedstate throughout their life cycle.
质量管理系统应该到位，以确保它们在整个生命周期中保持确认状态。
1.3 Productsshould be manufactured on qualified equipment.
产品应使用经确认的设备生产。
1.4 Manufacturerswho may u an alternative verification framework to achieve qualification should ensure the qualificationexpectations within this guide are satisfied.
生产商也可以使用另一种验证框架来完成确认，以确保满足本指南中的确认期望。
2. SCOPE 范围
2.1 Theguidelines describe the general approach to qualification, for
example,premis,systems, computerized system,utilities and equipment.
这些指南描述了确认的一般方法，例如厂房、系统、计算机化系统、公用系统和设备。
2.2 The principlesin the guidelines may also be applied to the qualification of
instruments,analytical instruments and testing devices, where appropriate.
在适当情况下，这些指南的原则也可适用于仪器、分析仪器和测试装置的确认。
2.3 The mayinclude and are not limited to: certain rooms; water purification
systems;cleaning systems; heating, ventilation and air conditioning systems; compresdair systems; gas systems;steam systems; as well as production equipment and analytical instruments.
这些可能包括但不限于：特定房间；水系统；清洗系统;HVAC系统；压缩空气系统；其他气体系统；蒸汽
系统；以及生产设备和分析仪器。
2.4 Separateguidelines in this ries address other principles in validation such asprocess
validationand cleaning validation (e references at the end of this document).
本系列中单独的指南方针讨论了验证中的其他原则，如工艺验证和清洁验证(请参阅本文末尾的
参考资料)。
吊兰的栽培方法2.5 The principlecan be ud when de-commissioning equipment to show that it remains fit for its purpo throughout the life cycle.
当设备退役时，可以使用该原理来表明它在整个生命周期中始终适用其用途。
3. GLOSSARY 术语
computerizedsystem. A computerizedsystem collectively controls the performance
andexecution of one or more automated process and/or functions. It includescomputerhardware, software, peripheraldevices, networks and documentation, for example, manuals and standard operating procedures (SOPs), aswell as personnel interacting with hardware and software.
计算机化系统。计算机化系统集体控制一个或多个自动化过程和/或功能的性能和执行。它包括计算机硬件、软件、外围设备、网络和文件，例如手册和标准操作程序，以及与硬件和软件交互的人员。
designqualification. Documentedevidence that, for example, the premis, supporting systems, utilities and equipment have beendesigned for their intended purpos and in accordance with the requirements of goodmanufacturing practices (GMP).
设计确认。有文件证明，例如，厂房、支持系统、公用设施和设备是按照其预期目的和药品生产质量管理规范(GMP)的要求设计的。
factoryacceptance test. A testconducted, usually at the vendor’s premis, to verify that the system, equipment or utility, asasmbled or partially asmbled, meets approved specifications. (new)
工厂验收测试。一种测试，通常在供应商场所进行，以确认组装或部分组装的系统、设备或公用设施是否符合批准的规格。(新)
installationqualification. Theperformance of tests to ensure that the installations (such as machines, measuring devices, utilitiesand manufacturing areas) ud in a manufacturing process are appropriately lected andcorrectly installed and operate in accordance with established specifications.
安装确认。确保在制造过程中使用的设备(如机器、测量设备、公用设施和制造区域)按照既定的规格被适当地选择，正确地安装和操作。
operationalqualification. Documentedverification that the system or subsystem performs as intended over all anticipatedoperating ranges.
运行确认。用文件来确认系统或子系统在所有预期的操作范围内按预期运行。
performancequalification. Documentedverification that the equipment or system operates consistently and givesreproducibility within defined specifications and parameters for prolonged periods. (In the context ofsystems, the term “process validation” may also be ud.)
性能确认：有文件证明设备或系统运行一致，并在规定的规格和参数内提供长时间的重现性。(在系统上下文中，也可以使用“工艺验证”一词。)
site acceptancetest. A test conducted atthe site of u to verify that the system,
equipmentor utility, as asmbled or partially asmbled meets approved specifications. (new)
现场验收测试：在使用现场进行的测试，以验证组装或部分组装后的系统、设备或公用设施是否符合批准的规格。(新)
system. A regulated pattern of interactingactivities and techniques that are united to form an organized whole.学校的简笔画
系统：相互作用的活动和技术的规范模式，它们联合起来形成一个有组织的整体。
urrequirement specifications.An authorized document that defines the requirements for u of the system, equipment or utilityin its intended production environment. (amended)
用户需求说明：在预期的生产环境中定义系统、设备或公用设施使用要求的授权文件。(修改)
utility. A system consisting of one or morecomponents to form a structure designed to
盼课文collectively operate, function or performand provide a rvice such as electricity, water, ventilation or other. (new)
公用设施。一种由一个或多个部件组成的系统，形成一种结构，其设计目的是共同操作、工作或提供服务，如电力、水、通风或其他。(新)
4. GENERAL 概述
Note: Theremainder of the text in the guidelines will refer to utilities and equipmentaxamples, even though theprinciples may be applicable to others such as premis and systems.
注：本指南的其余部分将以公用工程和设备为例，尽管这些原则可能适用于其他领域，如厂房和系统。
4.1 The validationmaster plan, or other relevant document, should specify the policy, organization, planning, scope and stagesapplied in qualification on site, and should cover, for example, production, quality control andengineering.
验证主计划或其他相关文件应详细说明在现确认中应用的政策、组织、计划、范围和阶段，并应包括，例如，生产、质量控制和工程。
4.2 Quality riskmanagement principles should be applied in qualification. The include:
确认应使用质量风险管理原则。包括：
· Aclear understanding of the system, and the role it plays in establishing/protecting the process andquality and all of the potential ways (risks) the process or quality could be impacted byfailures, events, errors, or time/u-bad factors (deterioration, out of tolerance instruments,wear and tear, and so on);
系统的清晰的理解, 它在建立/保护工艺和质量中所起的作用，以及工艺或质量可能受到失败、事件、错误或基于时间/使用的因素(损坏、超出波动允许范围的仪器、磨损等)的影响的所有潜在方法(风险);
l Defining all of the Design, Procedural and/orQuality System Controls required to protect against the potential risks.The controls either mitigate/reduce the risks and/or detect
the impact to quality orprocess – should the risk occur. (To ensure the “failure” does not impact final productquality);
定义所有的设计、程序和/或质量体系控制，以防止这些潜在的风险。这些控制可以减轻/减少风险和/或检测风险发生时对质量或工艺的影响。(确保“故障”不影响最终产品质量);
Compiling evidence during the design,engineering, commissioning and qualification to demonstrate that all of therequired “controls” have been properly implemented and verified. (Including“function” where applicable – such as alarms on operatingparameters);
在设计、工程、调试和确认过程中收集证据，以证明所有这些必需的“控制”都得到了适当的实施和确认。(包括“功能”(如适用)-例如有关操作参数的报警);
· Appropriate control and oversight of changeonce the controls have been verified.
一旦控制得到确认，对变更进行适当的控制和监督。
4.3 The scope andextent of qualification and requalification should be determined bad on the principles of impact asssment andrisk management principles.
确认和再确认的范围和程度应根据影响评估原则和风险管理原则确定。
4.4 Qualificationshould be executed by trained personnel. Training records should be maintained.
确认应由经过培训的人员执行。应保存培训记录。
4.5 Whereappropriate, new premis, systems, utilities and equipment should be subjectedtoall stages of qualification.This includes the preparation of ur requirement specifications (URS),design qualification (DQ), installation qualification (IQ), operationalqualification (OQ) and performance qualification (PQ).
在适当情况下，新厂房、系统、公用设施和设备应进行所有的确认检查。包括编写用户需求说明(URS)、设计确认(DQ)、安装确认(IQ)、运行确认(OQ)和性能确认(PQ)。
4.6 Justificationshould be provided where it is decided that not all stages of qualification are required.
当决定不需要进行完整确认阶段时，应提供理由。
4.7 Qualificationshould be done in accordance with predetermined and approved qualification protocols. The protocolshould specify the prerequisites and test details, including acceptance criteria.
确认必须按照预先确定和批准的确认方案进行。方案应该指定先决条件和测试细节，包括验收标准。
4.8 The results ofthe qualification should be recorded and reflected in qualification reports.
确认的结果应当记录在案，并反映在确认报告中。
4. 9 Aqualification report prepared at the completion of each protocol or stage ofqualification (Installation/Operational/Performance) should include, orreference as appropriate, the following:
检讨书范文在每个确认报告或确认阶段(安装/运行/性能)完成时编制的确认报告应包括或酌情参考以下内容:
testresults, including supporting calculations, documentation and raw/original data,
测试结果，包括支持性计算、文件和原始数据。
test failures, 测试失败的情况
protocol departures, 方案偏离情况
recommendations and justification for issue resolution, and 问题解决的建议和理由conclusions. 结论
4.10 There shouldbe a logical quence for executing qualification, such as premis (rooms), thenutilities and equipment.
应该有一个执行确认的逻辑顺序，例如厂房(房间)，然后是公用设施和设备。
4.11 Normally,qualification stages should be quential. (For example, operational
刘公岛景区qualificationshould follow after the successful completion of installation qualification.)In some cas, different stages of qualification may be executed concurrently.This should be justified and documented in the validation master plan (or qualificationprotocol).
通常，确认阶段应该是连续的。(例如，运行确认应该在成功执行安装确认后进行。)在某些情况下，确认的不同阶段可以同时执行。这应该在验证主计划(或验证方案)中证明并记录在案。
4.12 Equipmentshould be relead for routine u only once there is documented evidence that the qualification has been successful.
只有在有文件证明确认成功执行的情况下，设备才应放行用于日常使用。
4.13 Certainstages of the qualification may be done by a supplier or a third party, subjecttothe conditions andresponsibilities as defined in a written agreement between the parties. The contract giver remains responsible toensure that the qualification is done in accordance with the principles of GMP.
确认的某些阶段可以由供应商或第三方完成，但须符合双方书面协议中规定的条件和责任。设备所有
方仍有责任确保确认符合GMP的原则。
4.14 The relevantdocumentation associated with qualification, including SOPs, specifications and acceptance criteria, certificates andmanuals, should be available.
应提供与确认有关的相关文件，包括标准操作规程、规范和验收标准、证书和手册，应生效。
4.15 Utilities andequipment should be maintained in a qualified state and should be periodically reviewed for the need forrequalification. Requalification should be considered when changes are made.
公用设施和设备应保持在确认状态，并应定期审查是否需要再确认。如果有变更，应该考虑再确认。
5. USERREQUIREMENT SPECIFICATIONS用户需求说明
5.1 URS should beprepared for, but not limited to, utilities and equipment, as appropriate.
公用设施和设备应该准备URS，但不限于此。
5.2 URS should beud at later stages in qualification to verify that the purchad and supplied utility or equipment is inaccordance with the ur’s needs.
URS在确认的后期阶段使用，以确定购买和提供的公用设施或设备是否符合用户的需要。
6. DESIGNQUALIFICATION 设计确认
6.1 DQ shoulddemonstrate that the system, as designed, is appropriate for its intended uasdefined in the URS.
DQ应证明系统的设计适用于URS所界定的预期用途。
6.2 A suitablesupplier should be lected and approved for the relevant utility or equipment.对于相关的公用设施或设备，应选择批准的合适的供应商。
7. FACTORYACCEPTANCE TEST AND SITE ACCEPTANCE TEST
FAT和SAT
主要政治表现
7.1 Where autility or equipment is asmbled, or partially asmbled at a site other thanthatof the purchar or end-ur,testing and verification may be done, bad on quality risk management principles, to ensure that it isappropriate and ready for dispatch.
如果公用设施或设备是在买方或最终用户以外的地点组装或部分组装的，则可以根据质量风险管理原则进行测试和验证，以确保该设备是适当的，并已准备好进行分派。
7.2 The checks andtests during factory acceptance test (FAT) should be recorded.
工厂验收测试(FAT)期间的检查和测试应记录在案。
7.3 Theacceptability of the asmbly and overall status of the utility or equipmentshould bedescribed in a conclusion ofthe report for the FAT, prior to shipment.
在装运前，关于FAT报告的结论应说明装配的可接受性和公用设施或设备的总体状况。
7.4 Tests, badon quality risk management principles, may be performed to verify the acceptability of the utility or equipmentwhen it is received at the end-ur. This is a site acceptance test (SAT).
根据质量风险管理原则，可以进行测试，以验证公用设施或设备在最终用户收到时是否可接受。这是一个现场验收测试(SAT)。
7.5 The results ofthe tests should be evaluated and the outcome of the acceptability of the utility or equipment should be recorded inthe conclusion ction of the report for the SAT.
应评估测试结果，并在SAT报告的结论部分记录共用设施或设备的可接受标准的结果。
8. INSTALLATIONQUALIFICATION 安装确认
8.1 Utilities andequipment should be correctly installed, in an appropriate location.
公用设施和设备应正确安装在适当的位置。大象英语怎么说
8.2 There shouldbe documented evidence of the installation. This should be in accordance with the IQ protocol which contains all therelevant details.
应该有安装的证明文件。这应该符合IQ方案，它包含了所有相关的细节。
8.3 IQ shouldinclude identification and installation verification of relevant components identified, e.g. rvices, controls andgauges.
IQ应该包括相关组件的识别和安装确认，例如服务、控制和仪表。
8.4 Identifiedmeasuring, control and indicating devices, should be calibrated on site unless otherwi appropriately justified. Thecalibration should be traceable to national or international standards. Traceable certificates should beavailable.
用于测量、控制和指示装置应在现场进行校准，除非另有适当理由。校准应符合国家或国际标准。应提供可追溯的证书。
8.5 Deviations andnon-conformances, including tho from URS, DQ and acceptance criteria specified and obrved duringinstallation, should be recorded, investigated, and corrected or justified.
